Distal radius plate

ABSTRACT

A distal radius plate according to the invention is ergonomically formed to be more easily centered on the radius bone. The distal radius plate has two main portions: an elongated portion that attaches to the body of the radius and a distal radius portion that attaches to the lower most, wider portion of the radius bone. Because of its ergonomic shape the distal radius plate is fast and easy to center on the radius and install. In another embodiment, the distal radius plate may include a metal support that is partially or entirely covered with a plastic to eliminate or reduce detailed machining of the metal, which reduces part cost and manufacturing time

CROSS-REFERENCE TO RELATED APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

The present application is a continuation of U.S. patent applicationSer. No. 15/146,824, filed May 4, 2016, entitled “DISTAL RADIUS PLATE,”which claims a priority benefit under 35 U.S.C. § 119(e) of U.S.Provisional Application Ser. No. 62/163,912, filed May 19, 2015,entitled “DISTAL RADIUS PLATE.” The entirety of each of theaforementioned applications is hereby incorporated by reference herein.

FIELD AND BACKGROUND OF THE INVENTION

The forearm has two large bones, the radius and the ulna, which runparallel to one another. The proximal end of the radius is at thelateral side of the elbow and extends all the way to the thumb side ofthe wrist which is the distal end of the radius (from a referenceposition in which the palm of the hand faces forward). The radius canalso be divided in its other dimensions. For example the palm side ofthe radius bone is called the “volar” and the other side is called“dorsal.” The volar distal radius therefore refers to the palm side ofthe distal radius. The most prominent region (the part that sticks outlike a ridge line) of the volar distal radius is called the “watershedline.” A distal radius fracture is a common bone fracture of the distalend of the radius in the forearm.

Surgical implantation of a fixation (called a radius plate herein) plateto secure a broken radius has significantly helped revolutionizetreatment of distal radius injuries. The plate may be fixed adjacent tothe bone to be healed and is held in place using screws. There are manydifferent techniques for treating distal radius fractures includingdorsal plating, fragment specific fixation, non-spanning externalfixation, volar plating, spanning internal fixation plates.

Locked volar plating is a commonly used technique that has significantlyimproved the value of treatment. The volar plate has holes and isaffixed by screws that run through holes in the plate.

Notwithstanding its value, a well-known complication of volar plating isirritation and/or rupture of the tendons, especially flexor tendons. Theidea is to keep the bone fragments of the fracture together securelywithout causing irritation or rupture of the tendons. The most commonway to position the volar plate is to position it at or just proximal tothe watershed line of the distal radius.

Other prior art devices for securing are known that affix solely to theradius. These devices normally have an elongated section that extendsalong the body part of the radius prior to its distal end near thewrist. At the distal end, which is wider than the body, a plateconnected to the elongated portion is affixed, normally by screwing intoplace.

Some common problems with the aforementioned prior art devices are (1)they are difficult to center on the radius bone, (2) they sometimesrotate out of being centered after first being affixed, (3) they are notshaped like the distal end of the radius and may not secure it properly,and (4) they are not shaped properly, and do not have the proper screwholes or locations, to cover every size arm/hand (or at least a largerange of arm/hand sizes).

SUMMARY OF THE INVENTION

As used herein with respect to the radius bone, “body” or “body portion”means the long part of the radius bone extending up the arm from thedistal radius. “Distal radius” means the part of the radius bone at itsdistal end, near the wrist and thumb. The “elongated portion” of adistal radius plate is the portion that is affixed to the body of theradius bone. The “distal radius portion” or “radius portion” of a distalradius plate is the portion that affixes to the distal radius.

There are two aspects of the invention. One is a distal radius plateformed entirely of metal, such as stainless steel. The other is a distalradius plate with a metal support for strength and rigidity, which isoverlaid with plastic. The plastic overlay forms, or eliminates the needfor, complex shapes that must be machined into the metal, therebyreducing the cost of making and the cost and time to manufacture thedistal radius plate.

A distal radius plate according to invention has two basic portions, anelongated portion and a distal radius portion. Each is ergonomicallydesigned to follow the shape of the radius bone. The distal radiusportion is asymmetric and follows the outline of the distal radius overpreferably 80 percent of its lower-most part. This helps center theentire distal radius plate and better aligns with the radius bone tosecure the bone when affixed to it.

A distal radius plate according to aspects of the invention may have astraight line down at least the top surface elongated portion, andpreferably along both the elongated and distal radius portion to enablea surgeon to determine quickly when the plate is centered on the radiusbone.

When installing a distal radius plate, the incision in the arm/wrist issometimes small and it can be difficult to determine the exact platealignment. Therefore, the ability for a surgeon to quickly andaccurately center the distal radius plate on the radius bone isdesirable.

A distal radius plate according to the invention may also have a stop,which can be a piece of metal attached to the elongated portion and thatextends around the side of the plate on the thumb side. This preventsover rotation of the plate. The stop is preferably at the most proximalend of the distal radius plate.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top, perspective view of a device according to aspects ofthe invention.

FIG. 2 is a top view of the device of FIG. 1.

FIG. 3 is a side view of the device of FIG. 1.

FIG. 4 is a top perspective view of the device of FIG. 1.

FIG. 5 is a bottom perspective view of the device of FIG. 1.

FIG. 6 is a top, x-ray view of the device of FIG. 1 attached to a radiusbone.

FIG. 7 is a top view of the device of FIG. 1 attached to a radius bone.

FIG. 8 shows top views of a metal support and plastic overlay that canbe used to form a different embodiment of the invention.

FIG. 9 shows the plastic overlay of FIG. 8 attached to a metal support.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

Turning now to the drawings wherein the purpose is to describe apreferred embodiment of the invention and not to limit same. FIG. 1shows a top, perspective view of a distal radius plate 10 in accordancewith aspects of the invention. Distal radius plate 10 is preferablycomprised of metal, such as stainless steel. Plate 10 has two mainportions: elongated portion 100 and distal radius portion 200. Elongatedportion 100 has a top side 102, a bottom side 104 and a distal end (orend) 106. Top side 102 is smooth and has a centerline 108 stamped orotherwise formed therein, or centerline 108 could be printed. A slot 110is formed in portion 100 and has an upper opening 112, which is largeenough to receive and retain a screw head, and a lower opening 114,which is large enough for a screw body to pass through and thread intothe body of the radius bone, but too small for the screw head to passthrough.

Between slot 112 and end 106 are three first openings 116 shown as beingcentered in elongated portion 100. Although three openings 116 areshown, one or more first openings 116 may be utilized. The purpose ofopenings 116 is for screws to pass through and screw into the radiusbody thus affixing elongated portion 100 to the elongated body. Openings116 are preferably formed at angles so that openings 116A and 116C areskewed in one direction by 5°-10°, and preferably 10°, or from 5°-20°.Opening 116B is preferably skewed in the opposite direction by the sameamount. This skewing forces the screws going through the respectiveopenings to enter the radius body at different angles, which makes itmore difficult for the elongated portion 100, and distal radius plate10, from rotating.

End 106 is tapered to a rounded edge 106A and has an inner stop 106Bthat prevents it from rotating on the radius body. Stop 106B is shapedlike a hook so if the distal radius plate rotates, the outer edge of thestop presses against the body of the radius bone preventing furtherrotation.

Bottom side 104 is concave to more easily be fit to and centered on theradius body.

There is preferably an intermediate section 118 with an elongatedportion 100 and the distal radial portion 200. Intermediate portion alsowidens into portion 200. Considering the upward bend in the intermediateportion 118, portion 200 is preferably about ¼″ to ½″ offset from (orhigher than) elongate portion 100.

Distal radius portion 200 is wide relative elongated portion 100 and ispreferably shaped to approximate the shape of the distal radius part ofthe radius bone. As used herein, the distal radius portion refers to thelower most portion of the radius bone, which is near the wrist. Portion200 is lower on the radius bone and arm when installed.

Portion 200 has a top surface 202, a bottom surface 204, an aperture 206and a plurality of second openings 208. Openings 208 as shown are inthree sets formed at three different angles. There is a first set 208A(for large distal radiuses), a second set 208B for smaller distalradiuses and a third set 208C for further anchoring to a distal radiusof appropriate sizes. Fasteners 210 fit through the respective openingsand are affixed to the distal radius preferably by being threaded intothe bone and the fastener heads are countersunk into the openings. Asurgeon can determine which openings to place fasteners throughdepending on the size of the distal radius. Further, the angles of thesecond openings may permit the fasteners to crisscross, which providescompressive strength.

Portion 200 has an end 212, a side 214, and a side 216. End 212, side214 and side 216 are preferably the same shape of the distal radius forat least 50% of the distance from portion 100 moving towards end 212, orfor at least 75% of the distance from portion 100 moving towards end212, or for at least 80% of the distance from portion 100 moving towardsend 212.

The distal radius plate according to various aspects of the inventioncan be quickly centered and attached, and one size fits most or allradius bones.

In use, an opening is made in the arm and the distal radius plate iscentered on the radius bone using concave surface 104 and centerline108. Then a fastener is positioned through slot 110 and screwed into theradius body. Distal radius plate 10 can be moved back and forth alongslot 110 to properly position portion 200 over the distal radius. Theslot also permits limited side-to-side movement to center the distalradius plate.

In another embodiment shown in FIGS. 8 and 9, a distal radius plateaccording to the invention has a metal support and plastic overlay. Themetal support preferably comprises steel, such as stainless steel. Theplastic overlay can be comprised of any suitable material, such as PEEK.The advantage of the plastic overlay is that it reduces production timeand costs little or no complex machining of the metal need be performed.Specific embodiments of a distal radius plate with a plastic overlay aredescribed below and shown in some of the attached drawings.

By using a plastic overlay, the metal support can simply be stampedusing a stamping tool. The smooth edges, the distal edge of theelongated portion and the shape of the distal radius portion can beformed in the plastic made by an injection molding process or anothersuitable process. Furthermore, the first openings and second openingsneed not be machined at angles—they can be punched straight through themetal support. The plastic can partially fill the openings and a surgeoncan thread a fastener through the plastic and into the radius bone atany angle he/she desires.

A plastic overlay may be manufactured separately and attached to themetal support, for example, by pressure fitting them together. Or, theplastic may be formed over the metal support.

Having thus described preferred embodiments of the invention, othervariations and embodiments that do not depart from the spirit of theinvention will become apparent to those skilled in the art. The scope ofthe present invention is thus not limited to any particular embodiment,but is instead set forth in the appended claims and the legalequivalents thereof. Unless expressly stated in the written descriptionor claims, the steps of any method recited in the claims may beperformed in any order capable of yielding the desired result.

Some specific, exemplary embodiments of the invention are describedbelow.

1. A distal radius plate having:

-   -   (a) an elongated portion with one or more first openings, the        elongated portion for being attached to the body portion of the        radius bone; and    -   (b) a distal radius portion with one or more second openings,        wherein at least some of the openings are formed at outward        angle; wherein screws passing through the one or more first        openings are received in the body portion and screws passing        through the one or more second openings are received in the        distal radius.

2. The distal radius plate of example 1 wherein there is a upward bendbetween the elongated portion and the radius portion.

3. The distal radius plate of example 2 wherein the radius portion is ¼″to ½″ above the elongated portion.

4. The distal radius plate of any of examples 1-3 that includes a slotin the elongated portion, the slot for receiving a screw to anchor andcenter the elongated portion on the body portion.

5. The distal radius plate of example 4 wherein the slot is between ½″and 1½″ in length.

6. The distal radius plate of any of examples 1-5 wherein there aremultiple first openings.

7. The distal radius plate of example 6 wherein the elongated portionhas an end distal the distal radius portion and an end proximal thedistal radius portion and each of the first openings is between thedistal end and the slot.

8. The distal radius plate of any of examples 1-7 wherein the elongatedportion has a visible center line to assist in centering the distalradius plate on the radius bone.

9. The distal radius plate of any of examples 1-8 wherein the elongatedportion has an end distal the distal radius portion and the distal endis tapered to form a rounded edge.

10. The distal radius plate of any of examples 1-9 wherein the distalradius portion has different second openings formed at different anglesin order to accommodate different-sized distal radiuses.

11. The distal radius plate of any of examples 1-10 wherein the distalradius portion has an enlarged opening between the second openings andthe elongated portion.

12. The distal radius plate of example 10 wherein there is a first setof second openings to fit one sized hand and a second set of secondopenings to fit a different sized hand, wherein the first set of secondopenings are formed at different angles than the second set of secondopenings.

13. The distal radius plate of any of examples 1-12 wherein each of thesecond openings has a locking mechanism to hold a fastener in place.

14. The distal radius plate of any of examples 1-13 wherein the shapeand size of the distal radius portion enables it to self center on thedistal radius bone.

15. The distal radius plate of any of examples 1-13 wherein the distalradius portion has the shape of the distal radius.

16. The distal radius plate of any of examples 1-15 wherein the at leasttwo second openings are positioned such that at least one bone portionin the distal radius can be engaged by at least two fasteners.

17. The distal radius plate of any of examples 1-15 wherein the secondopenings are positioned such that more than one bone portion in thedistal radius can be engaged by more than one fastener.

18. The distal radius plate of any of examples 1-17 wherein theelongated portion has a top surface, and a bottom surface that restsagainst the body of the radius bone, the bottom surface being concave.

19. The distal radius plate of any of examples 1-18 wherein theelongated portion has an end distal the distal radius portion and thedistal end has a flange.

20. The distal radius plate of any of examples 1-19 wherein there is afirst set of second openings to fit one sized hand and a second set ofsecond openings to fit a different sized hand, wherein the first set ofopenings are positioned farther from the center of the distal radiusportion than the second set of openings.

21. The distal radius plate of any of examples 1-20 wherein at least theupper half of the distal radius portion is shaped the same as the distalradius bone.

22. The distal radius plate of any of examples 1-20 wherein at least theupper 75% of the distal radius portion is shaped the same as the distalradius.

23. The distal radius plate of any of examples 1-22 wherein the bottomof the elongated portion has a stop including a ridge to preventrotation.

24. The distal radius plate of example 23 wherein the stop is at the endof the elongated portion distal from the distal radius portion.

25. The distal radius plate of example 4 wherein the slot accepts ascrew that is threaded into the radius bone body and the distal radiusplate can slide along the radius bone with the screw maintaining theside-to-side position of the distal radius plate.

1.-25. (canceled)
 26. A method of stabilizing a fractured radius of a patient using a plate that comprises an elongated portion and a distal radius portion, the method comprising: centering the plate on the radius bone using a visible centerline positioned on the elongated portion of the plate; attaching the elongated portion of the plate to an elongated body part of the fractured radius using a fastener including a stem with a first diameter and a head with a second diameter that is greater than the first diameter, the elongated portion comprising a slot that includes an upper opening sized to receive the head of the fastener and a lower opening sized to receive the stem of the fastener without allowing passage of the head of the fastener therethrough, wherein the stem of the fastener extends through the slot into the elongated body part of the fractured radius and the head is retained in the upper opening so as to anchor the elongated portion of the plate on the radius bone and to allow the plate to move lengthwise and side-to-side to be adjusted relative to the radius bone; affixing the elongated portion to the body part of the fractured radius using one or more first fixation devices through one or more first openings in the elongated portion; and affixing the distal radius portion of the plate to a distal radius part of the fractured radius using one or more second fixation devices through one or more second openings in the distal radius portion of the plate.
 27. The method of claim 26, wherein at least two of the first openings are skewed in generally opposite directions so as to force the first fixation devices through the respective first openings to enter the elongated body part of the fractured radius at different angles.
 28. The method of claim 26, wherein the elongated portion comprises a free end further away from the distal radius portion and an opposite end closer to the distal radius portion, and each of the first openings is between the free end and the slot.
 29. The method of claim 26, wherein the slot is between ½″ and 1½″ in length.
 30. The method of claim 26, wherein the plate comprises a bend extending from the elongated portion to the distal radius portion.
 31. The method of claim 26, wherein the distal radius portion comprises a first set of second openings to fit a fractured radius of a first size and a second set of second openings to fit a fractured radius of a second size that is different from the first size.
 32. The method of claim 31, wherein the first set of second openings are formed at different angles than the second set of second openings.
 33. The method of claim 26, wherein the distal radius portion comprises a shape and size that enables the distal radius portion to self-center on a distal radius part of the fractured radius.
 34. The method of claim 26, wherein the second openings are positioned such that more than one area in the distal radius part are engaged by more than one second fixation devices.
 35. The method of claim 26, wherein the elongated portion comprises a top surface and a bottom surface, the bottom surface configured to rest against the elongated body part of the fractured radius, and the bottom surface being concave.
 36. The method of claim 35, wherein the bottom surface of the elongated portion comprises a stop including a ridge to prevent rotation.
 37. The method of claim 36, wherein the stop is at a free end of the elongated portion.
 38. The method of claim 35, wherein the visible centerline is located on the top surface.
 39. A method of stabilizing a fractured radius of a patient using a plate, the method comprising: centering the plate on the radius bone using a visible centerline positioned on the plate; attaching the plate to an elongated body part of the fractured radius using a fastener including a stem with a first diameter and a head with a second diameter that is greater than the first diameter, the plate comprising a slot that includes an upper opening sized to receive the head of the fastener and a lower opening sized to receive the stem without allowing passage of the head of the fastener therethrough, wherein the stem of the fastener extends through the slot into the elongated body part of the fractured radius and the head is retained in the upper opening so as to anchor the plate on the radius bone and to allow the plate to move lengthwise and side-to-side to be adjusted relative to the radius bone; and affixing the plate to the fractured radius using a plurality of fixation devices through a plurality of openings located on the plate and proximal and distal of the slot.
 40. The method of claim 39, wherein the slot is between ½″ and 1½″ in length.
 41. The method of claim 39, wherein the plate comprises a bend extending from an elongated portion to a distal radius portion.
 42. The method of claim 41, wherein the slot is located on the elongated portion.
 43. The method of claim 39, wherein the plurality of openings distal of the slot comprises a first set of openings to fit a fractured radius of a first size and a second set of openings to fit a fractured radius of a second side different from the first size.
 44. The method of claim 43, wherein the first and second sets of openings are formed at different angles.
 45. The method of claim 39, wherein at least two of the plurality of openings are skewed in generally opposite directions so as to force the plurality of fixation devices to enter the fractured radius at different angles. 